BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 4143060 · Received September 23, 2014

    Report

    Report Number
    1627487-2014-06289
    Event Type
    Injury
    Date Received
    September 23, 2014
    Report Date
    August 29, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-001-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RECALL: 1627487-05242011-002-R, 1627487-07262012-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES AND A FIELD CORRECTION. SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 5. REF. MFR. REPORTS: 1627487-2014-06290, 1627487-2014-06291, 1627487-2014-06292, 1627487-2014-06293. THE PT HAD TWO SCS SYSTEMS IMPLANTED. ONE SYSTEM FOR HIS THORACIC REGION (IMPLANTED ON (B)(6) 2009) AND ONE FOR HIS CERVICAL REGION (IMPLANTED ON (B)(6) 2012). INFO PROVIDED BY THE PT'S ATTORNEY, INDICATED THE PT ALLEGES THE FOLLOWING ISSUES: THE PT EXPERIENCED RANDOM OVERSTIMULATION AND BURNING WHILE CHARGING. HIS IPG'S (THORACIC AND CERVICAL) EVENTUALLY STOPPED HOLDING A CHARGE AND THE PT IS NO LONGER RECEIVING STIMULATION FROM EITHER OF HIS SCS SYSTEMS. APPROXIMATELY A YEAR AGO THE PT REPORTED HAVING TROUBLE COMMUNICATING USING HIS CHARGER (3721 AND 3722) WITH BOTH IPG'S. THE PT WAS SENT TWO REPLACEMENT CHARGERS (3722) TO ADDRESS THE ISSUE. AN SJM REPRESENTATIVE MADE SEVERAL ATTEMPTS TO CONTACT AND MEET WITH THE PT FOR TROUBLESHOOTING AND REPROGRAMMING; HOWEVER, THE PT DID NOT SHOW UP FOR THE SCHEDULED APPOINTMENTS AND REFUSED TO TROUBLESHOOT OVER THE PHONE. ADDITIONAL INFO IS NEEDED TO CLARIFY THE NATURE OF THE PT'S ISSUES. SJM WAS MADE AWARE OF THE ISSUES ON (B)(6) 2014, AND THE PT'S SCS SYSTEM HAS NOT BEEN EVALUATED BY AN SJM REPRESENTATIVE TO VERIFY AND/OR TROUBLESHOOT ANY OF THE REPORTED ISSUES. ON 08/01/2012 ST. JUDE MEDICAL, NEUROMODULATION DIVISION, SENT FIELD ACTION LETTERS TO PTS RELATED TO HEATING WHILE CHARGING AND RAISED AWARENESS OF THIS ISSUE TO PTS. AN INCREASE IN PRIOR NON-REPORTED HEATING WHILE CHARGING EVENTS AND OTHER NON-REPORTED EVENTS WAS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591022 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 2834058

    Patients

    Seq Age Sex Outcome Treatment
    1 Other